gentamicin sulfate

Generic: gentamicin sulfate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin sulfate
Generic Name gentamicin sulfate
Labeler asclemed usa, inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

gentamicin sulfate 3 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-254
Product ID 76420-254_e425b6aa-1415-785f-e053-2a95a90a4350
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064048
Listing Expiration 2026-12-31
Marketing Start 1994-05-11

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420254
Hyphenated Format 76420-254

Supplemental Identifiers

RxCUI
310467
UNII
8X7386QRLV

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gentamicin sulfate (source: ndc)
Generic Name gentamicin sulfate (source: ndc)
Application Number ANDA064048 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (76420-254-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

76420-254-05 1 BOTTLE, DROPPER in 1 CARTON (76420-254-05) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

gentamicin sulfate (3 mg/mL)

Linked Drug Pages (1)

Gentamicin Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "e425b6aa-1415-785f-e053-2a95a90a4350", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["310467"], "spl_set_id": ["b59e49e0-640b-43c3-ad07-711d1bb154e9"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (76420-254-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "76420-254-05", "marketing_start_date": "20220719"}], "brand_name": "Gentamicin Sulfate", "product_id": "76420-254_e425b6aa-1415-785f-e053-2a95a90a4350", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "76420-254", "generic_name": "Gentamicin Sulfate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin Sulfate", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "3 mg/mL"}], "application_number": "ANDA064048", "marketing_category": "ANDA", "marketing_start_date": "19940511", "listing_expiration_date": "20261231"}